February 22, 2019

New CDC Guidelines for Vaccine Storage & Handling

Written by Garret Weigel | Pharmacy Safety

Last month, the CDC released a redesigned Vaccine and Storage Handling Toolkit, aimed at providing healthcare professionals recommendations and best practices for managing, storing, and monitoring vaccines to ensure potency. Temperature control is extremely important for vaccines, as any deviation risks the quality of the vaccine, and in turn, the safety of the patient. This post will outline some of the key takeaways from the newly redesigned Vaccine and Storage Handling Toolkit, and how to take the guidelines a step further to realize business improvements.


Temperature Monitoring Devices (TMD)

In order to maintain potency, vaccines need to be kept at proper storage temperatures, specifically between 36°F and 46°F. Vaccines remain stable in this tight temperature range, which makes temperature monitoring critical to ensure the viability of vaccines. The CDC has recommended a type of temperature monitoring devices (TMD): specifically digital data loggers (DDL). Many thermometers available today simply show minimum and maximum temperatures, which provides little insight into whether or not the vaccines remain potent. DDLs are capable of providing significantly more detailed reports into temperature variations of a particular fridge or freezer, which enables accurate analysis of the potency for the affected product.


The Advantages of Product Simulation

The CDC has acknowledged that there exists a real challenge with monitoring pharmaceutical products, even when using a DDL. Most temperature recording devices monitor ambient temperature, or the air temperature of the refrigeration unit, rather than the actual product temperature. Heat transfer is not instant, which means air temperature is not an accurate method of determining the effect of temperature change on vaccines. There are a few ways to combat this issue:

  1. Measure the product temperature directly.
    1. The first, most obvious method of figuring out the actual product temperature is to measure the vaccine directly. This would be the most accurate way to determine the temperature of the vaccine, but is not scalable nor practical. Between the need to measure each individual product to potentially damaging the packaging, this method is not a realistic way to determine actual product temperature.
  2. Use a buffered temperature probe.
    1. This method is specifically recommended by the CDC and provides a scalable and reasonable way to understand how temperature fluctuations impact product temperature. The “buffer” can be a number of materials, including liquids such as glycol, loose media like sand or glass beads, or solid material like Teflon or aluminum. The probe is placed within the material, which acts as a buffer to the heat transfer. These mediums are much more accurate in their methods of replicating product temperature than measuring ambient temperature alone.
  3. Simulate the actual temperature using computer models.
    1. Lastly, product temperature simulation using advanced algorithms provides a more accurate way to measure actual vaccine temperatures. In our research, we have found that computer models can be twice as accurate as buffered temperature probes, providing peace of mind that product temperature is being measured accurately and effectively. Additionally, no physical space is taken up by a simulation, and simulations can be extended indefinitely and replicate any product regardless of size or density.


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Having visibility into product temperature, as opposed to air temperature, enables more effective monitoring for safety and quality. Many false alarms caused by momentary changes to air temperature (such as a fridge door being opened) can be avoided. Furthermore, knowing the product temperature allows more accurate interpretation of the accumulated level of risk associated with the amount of time it went out of its target storage range.


Real-Time Alerting for Temperature Excursions

DDLs may require an on-site visit for analysis and does not provide proactive management of temperature excursions. By the time the excursion is detected, it may be too late to save the vaccines. While DDLs provide a significant improvement over simple minimum/maximum thermometers, cloud-based remote temperature monitoring provides a new means for managing temperature excursions. As soon as temperatures reach unsafe levels, a cloud-based monitoring solution can trigger alerts to be sent out to key stakeholders – including pharmacists and managers who can take action to save the precious inventory. The ability to prevent problems before they occur is not possible with simple thermometers or even some DDLs.


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Topics: Pharmacy Safety

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